RECALL: Diabetics in Canada at risk of blood sugar spikes from faulty insulin system

Canadians who use Omnipod insulin delivery systems are being urged to check their devices after a recall linked to a defect that could result in too little insulin being delivered, potentially leading to dangerous spikes in blood sugar.

Health Canada has issued a Type I recall — the agency’s most serious classification — for several Omnipod insulin management products after manufacturer Insulet identified a manufacturing issue affecting certain lots.

According to Health Canada, a small tear can develop in the pod’s soft cannula, the tiny tube that delivers insulin beneath the skin. The damage can allow insulin to leak before it reaches the body, resulting in reduced or interrupted insulin delivery.

The agency warns that users could experience high blood sugar due to the under-delivery of insulin. In severe cases, prolonged high blood glucose levels can lead to diabetic ketoacidosis (DKA), a potentially life-threatening medical emergency that requires immediate treatment.

Insulet said users may notice wetness on their skin or the pod’s adhesive, or smell insulin leaking from the device. However, the company cautioned that leaks may not always be visible, meaning users could receive less insulin than needed without realizing it.

For people using the Omnipod 5 system in Automated Mode, the device may generate an Automated Delivery Restriction alert if insulin delivery is affected. However, the company says users should not rely solely on pod alerts because the problem can occur without triggering a warning.

Health Canada said the recall affects specific lots of Omnipod 5 Automated Insulin Delivery System pods, Omnipod DASH pods and Omnipod Insulin Management System (Omnipod Eros) pods. Pods not included in the affected lots, remain safe to use.

People using the affected products should immediately check the lot number on their pod, pod tray or product box against the manufacturer’s list of recalled lots.

Anyone with an affected pod should stop using it immediately.

The manufacturer is asking customers to acknowledge the recall through an email titled “ACTION REQUIRED: Review and Acknowledge Field Safety Corrective Action for Omnipod Pods,” where they can also request replacement pods if their products are affected. Unused recalled pods will be returned using a kit provided by the company.

Insulet says users whose supply runs out because of the recall should contact their healthcare provider to discuss alternative methods of insulin delivery until replacement pods arrive.

According to the manufacturer, there have been 24 reports worldwide of serious adverse events linked to the defect, including hospitalizations and cases of diabetic ketoacidosis. No deaths have been reported.

For assistance, customers can contact Omnipod Product Support at 1-855-763-4636, available 24 hours a day, or visit the company’s recall website for instructions on checking affected lot numbers.